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Hydroxocobalamin and Butyrate for Ulcerative Colitis
NCT04259060Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jan 2024
- Primary completion
- Aug 2025
- Countries
- 1
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- hydroxocobalamin
- Conditions
- ulcerative colitis (UC)
01
Overview
Phase 2, randomised, double-blind trial in ulcerative colitis (UC) comparing Hydroxocobalamin + Butyrate with Placebo + Butyrate (2 arms). Primary endpoints: Change from Baseline fecal calprotectin at week 4, Incidence of Treatment-Emergent Adverse Events (AE) as assessed by CTCAE at 4 weeks and 1 more. Planned start Jan 2024; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Hydroxocobalamin + Butyrate
Hydroxocobalamin (1g or 2g daily) + Butyrate (240mg daily)
Placebo + Butyrate
Placebo + Butyrate (240mg daily)
03
Who it enrols
Adult patients with confirmed Ulcerative Colitis for >3 months, active disease (calprotectin > 200), and specific Mayo scores. Excludes patients with uncontrolled hypertension, chronic kidney disease, impaired hepatic function, C. difficile, Crohn's disease, or recent use of prohibited medications like anti-TNF agents.
04
Endpoints
Primary
Change from Baseline fecal calprotectin at week 4
Incidence of Treatment-Emergent Adverse Events (AE) as assessed by CTCAE
Clinical Symptoms assessed by Simple Clinical Colitis Activity Index (SCCAI)
Secondary
Assessment of urinary and plasma nitrite, nitrate levels and nitrosothiol levels
Normalization of fecal calprotectin below the upper limit of normal
Reduction of Mayo Score (Phase 2)
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